(157 days)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Surgical Mask (K210267). It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable Surgical Mask, K210267) is a surgical mask intended to meet Level 2 performance according to ASTM F2100:2019. The acceptance criteria and the device's reported performance are summarized in the table below:
| Test Item | Test Method | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration Resistance | ASTM F1862/F1862M-17 (according to ASTM F2100:2019) | Pass at 120 mmHg | 32/32 passed at 120 mm/Hg (Pass) |
| Flammability of Clothing Textiles | 16 CFR Part 1610 (according to ASTM F2100:2019) | Class 1 (≥3 Seconds burn time) | 32/32 Passed ≥3 Seconds burn Time-Class 1 (Pass) |
| Differential Pressure (Delta P) | EN 14683: 2019, Annex C (according to ASTM F2100:2019) | <6.0 mmH2O/cm2 | 32/32 Passed at <6 mmH2O/cm2 (Pass) |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-14 (according to ASTM F2100:2019) | ≥ 98% | 32/32 Passed at ≥ 98% (Pass) |
| Latex Particle Challenge (PFE) | 16 CFR Part 1610 (according to ASTM F2100:2019) | ≥ 98% (This seems to be a typo in the document, likely referring to Particulate Filtration Efficiency (PFE) test, which is part of ASTM F2100 Level 2 criteria) | 32/32 Passed at ≥ 98% (Pass) |
| Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic |
| Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating |
| Sensitization | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For performance tests like Synthetic Blood Penetration, Flammability, Differential Pressure, Bacterial Filtration Efficiency, and Latex Particle Challenge, a sample size of 32/32 was used as indicated by "32/32 Passed" in the results.
- Sample Size for Biocompatibility Tests: The document doesn't explicitly state the exact sample size (number of devices or extracts) used for the biocompatibility tests (Cytotoxicity, Irritation, Sensitization). It only states "Under the conditions of the study, the subject device extract was determined to be..."
- Data Provenance: The tests were conducted in a lab ("Samples submitted to the testing lab"). The document does not specify the country of origin of the lab or if the data is retrospective or prospective, beyond saying the tests were conducted to verify the proposed device met design specifications. These are non-clinical (laboratory) studies, not human subject studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable for this submission. The "ground truth" for the performance tests of a surgical mask is established by validated standardized test methods (e.g., ASTM, EN, ISO standards) and their predefined pass/fail criteria, not by expert consensus on clinical findings. Biocompatibility assessment is also based on established in-vitro and in-vivo biological evaluation standards.
4. Adjudication Method for the Test Set
- This is not applicable. As the evaluation involved standardized performance and biocompatibility laboratory tests, there was no need for an adjudication method by human experts. The results are quantitative and compared against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- This is not applicable. This is a 510(k) submission for a physical medical device (Disposable Surgical Mask), not an AI/software device. No MRMC comparative effectiveness study was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This is not applicable. This is a physical medical device; there is no algorithm or human-in-the-loop component.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is based on standardized test methods and their defined pass/fail criteria. For example:
- Performance: Measured values (e.g., pressure, filtration efficiency, burn time) are compared against the numerical criteria specified in ASTM F2100 Level 2, 16 CFR Part 1610, and EN 14683.
- Biocompatibility: Biological responses (e.g., cell viability, skin reactions) are assessed against the criteria for "non-cytotoxic," "non-irritating," and "non-sensitizing" as outlined in ISO 10993 standards.
8. The Sample Size for the Training Set
- This is not applicable. Since no AI or machine learning model is involved, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- This is not applicable. As there is no training set.
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July 8, 2021
Xiamen Eagledon Pharmaceutical Co., Ltd % Ruth Wu Consultant Kavalan Consulting Inc. 1100 First Ave. Ste 305 King of Prussia, Pennsylvania 19406
Re: K210267
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 29, 2021 Received: February 1, 2021
Dear Ruth Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210267
Device Name Disposal Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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The assigned 510(k) Number: K210267
Date of Preparation: June 30, 2021
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. "
1. Submitter's Information:
Xiamen Eagledon Pharmaceutical Co., Ltd No.220-228, Meihe 3rd Road, Xiamen, Fujian 361100 China Tel: +86-592-7231999 Contact Person: Aggie Zhang Email: aggie@eaglehealthItd.com
2. Application Correspondent:
Kavalan Consulting Inc 1100 First Ave, Ste 305 King of Prussia, PA 19406 Tel: +1 610-310-2793 Contact Person: Ruth Wu Email: ruthwu@kavalangroup.com
3. Subject Device:
The 510(K) number: Traditional Common Names: Surgical Mask Disposable Surgical Mask Trade Name: Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel Classification Name: Mask, Surgical Regulatory Class: II Product Code: FXX
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4. Predicate Device:
The 510(K) number: K153496 Manufacturer: Xiantao Rayxin Medical Products Co Ltd Common Names: Surgical Mask Surgical Face Mask Trade Name: Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel Classification Name: Mask, Surgical Regulatory Class: II Product Code: FXX
5. Device Description:
Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates.
Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile:
| Model | SKU# | Product Type | Package |
|---|---|---|---|
| YJ002 | YJ002-NS2-50 | Disposable Surgical Mask (Non-Sterile)Level 2 | 50 pcs/box,2000 pcs/carton |
| YJ002 | YJ002-NS2-10 | Disposable Surgical Mask (Non-Sterile)Level 2 | 10 pcs/bag,1500 pcs/carton |
6. Indication for Use:
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
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| Device | Disposable Surgical Mask | Disposable Surgical Face Mask | Result | |
|---|---|---|---|---|
| Manufacturer | Xiamen EagledonPharmaceutical Co., Ltd | Xiantao Rayxin MedicalProducts Co.,ltd. | - | |
| 510K number | K210267 | K153496 | - | |
| Model Name | Disposable Surgical Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Intended use | The Disposable Surgical Masksare intended to be worn toprotect both healthcarepersonnel and patients fromtransmission of microorganisms,body fluid and particulates.These surgical masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theseface masks are intended foruse in infection controlpractices to reduce thepotential exposure to blood andbody fluids. This is a singleuse, disposable device(s),provided non-sterile. | Same | |
| Model Type | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated,3 layers | Same | |
| Material | Outer layer | Polypropylene non-woven cloth | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene Melt blown cloth | Melt blown polypropylene filter | Same | |
| Inner layer | Polypropylene non-woven cloth | Spun-bond polypropylene | Same | |
| Nose piece | PE material +1 chrome platediron core 2mm width | Malleable polyethylene wire | Different* | |
| Ear loops | Polyester Spandex | Polyester | Different* | |
| Color | Blue | Blue | Same | |
| Dimension (Width) | 17.5cm±1cm | 17.5cm±1cm | Same | |
| Dimension (Length) | 9.5cm±1cm | 9.5cm±1cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single use, disposable | Single use, disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Fluid ResistancePerformance | 32/32 Passed at 120 mmHgASTM F1862 | 13/13 Passed at 120 mmHgASTM F1862 | Same | |
| Particulate FiltrationEfficiency | 32/32 Passed at ≥98%ASTM F2299-03 | 13/13 Passed at ≥98%ASTM F2299 | Same | |
| Bacterial FiltrationEfficiency | 32/32 Passed at ≥98%ASTM F2101-14 | 13/13 Passed at ≥98%ASTM F2101 | Same | |
| Differential Pressure | 32/32 Passed at <6mmH2O/cm2EN 14683: 2019, Annex C | 13/13 Passed at <5mmH2O/cm2 MIL-M36954C | Same | |
| Flammability | 32/32 Passed ≥3 Secondsburn Time-Class 1 16 CFR Part1610 | 13/13 Passed ≥3 Secondsburn Time-Class 1 16 CFR Part1610 | Same | |
| Biocompatibility | ||||
| Cytotoxicity | Under the conditions of thestudy, the subject device extractwas determined to be non-cytotoxic | Under the conditions of thestudy, the subject deviceextract was determined to benon-cytotoxic | Same | |
| Irritation | Under the conditions of thestudy, the subject device extractwas determined to be non-irritating | Under the conditions of thestudy, the subject deviceextract was determined to benon-irritating | Same | |
| Sensitization | ||||
| Under the conditions of thestudy, the subject device extractwas determined to be non-sensitizing | Under the conditions of thestudy, the subject deviceextract was determined to benon-sensitizing | Same |
7. Comparison of Technological Characteristics:
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- The Disposable Surgical Mask and the Surgical Face Mask compared in the above table are substantially similar in Performance and Indications for Use. The differences raised in this table does not raise the concern for safety or effectiveness of the Disposable Surgical Masks submitted by Xiamen Eagledon Pharmaceutical Co Ltd.
8. Summary of Non-Clinical Performance Testing:
Non-clinical tests were conducted to verify that the proposed device met all design specifications to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Samples submitted to the testing lab and passed the following performance tests:
- . Color: Blue
- . Dimension: 17.5cm x 9.5cm (Ear loops: 17.5 cm)
- Lot numbers: 20210405, 20210504, 20210517 .
| Test item(PerformanceLevel 2) | Test Method | Pass Criteria | Results |
|---|---|---|---|
| Synthetic BloodPenetrationResistance | ASTMF1862/F1862M-17Standard Test Methodfor Resistance ofMedical Face Masksto Penetration bySynthetic Blood(Horizontal Projectionof Fixed Volume at aKnown Velocity)according to ASTMF2100:2019 | Level 2: fluidresistant claim120mmHg | 32/32 passed at 120mm/Hg/Pass |
| Flammability ofClothing Textiles | 16 CFR Part 1610Standard for theFlammability ofClothing according toASTM F2100:2019 | Class 1 | 32/32 Passed ≥3Seconds burnTime-Class 1 /Pass |
| DifferentialPressure (Delta P) | EN 14683: 2019,Annex C Medical facemasks -Requirements andtest methodsaccording to ASTMF2100:2019 | Level 2:<6.0 | 32/32 Passed at <6mmH2O/cm2 / Pass |
| Bacterial FiltrationEfficiency (BFE) | ASTM F2101-14Standard Test Methodfor Evaluating theBacterial FiltrationEfficiency (BFE) ofMedical Face MaskMaterials, Using aBiological Aerosol ofStaphylococcusaureus according toASTM F2100:2019 | Level 2: ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Latex ParticleChallenge | 16 CFR Part 1610Standard for theFlammability ofClothing according toASTM F2100:2019 | Level 2: ≥ 98% | 32/32 Passed at ≥98% / Pass |
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Biocompatibility testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
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-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization
9. Summary of Clinical Performance:
No clinical study is included in this submission.
10. Conclusions:
The Conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210267, Disposable Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.